Cleared Traditional

K904074 - VITREORETINAL INFUSION CANNULA

K904074 is an FDA 510(k) clearance for VITREORETINAL INFUSION CANNULA, manufactured by Visitec Co.. The device is a Class 1 Ophthalmic device with product code HMX cleared through the Traditional 510(k) pathway after a 175-day FDA review.

K904074 · Visitec Co. · Ophthalmic device
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Feb 1991
Decision
175d
Days
Class 1
Risk

K904074 is an FDA 510(k) clearance for the VITREORETINAL INFUSION CANNULA. Classified as Cannula, Ophthalmic (product code HMX), Class I - General Controls.

Submitted by Visitec Co. (Sarasota, US). The FDA issued a Cleared decision on February 26, 1991 after a review of 175 days - an extended review cycle.

This device falls under the Ophthalmic FDA review panel, regulated under 21 CFR 886.4350 - the FDA ophthalmic device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Ophthalmic review framework, consistent with the majority of Class II 510(k) submissions.

View all Visitec Co. devices

FDA 510(k) Submission Details - K904074

510(k) Number K904074 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 04, 1990
Decision Date February 26, 1991
Days to Decision 175 days
Submission Type Traditional
Review Panel Ophthalmic (OP)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
65d slower than avg
Panel avg: 110d · This submission: 175d
Pathway characteristics
Predicate-based equivalence.

HMX Device Classification - Class 1, General Controls

Product Code HMX Cannula, Ophthalmic
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 886.4350
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.

Regulatory Peers - HMX Cannula, Ophthalmic

All 39
Devices cleared under the same product code (HMX) and FDA review panel - the closest regulatory comparables to K904074.
ASPIRATING ENDO OCULAR PROBE W/ILLUMINATION
K921488 · Surgical Technologies, Inc. · May 1992
STORZ INFUSION CANNULA
K882884 · Storz Instrument Co. · Aug 1988
PRISMA DISPOSABLE GILLS ANGLED I/A CANNULA
K874968 · Advanced Surgical Products, Inc. · Apr 1988
PRISMA DISPOSABLE KRATZ CAPSULE POLISHER
K874969 · Advanced Surgical Products, Inc. · Apr 1988
PRISMA DISPOS. TROUTMAN ALPHA-CHYMOTRYPSIN CANNULA
K874970 · Advanced Surgical Products, Inc. · Apr 1988
PRISMA DISPOSABLE PEARCE IRRIGATING VECTUS
K874971 · Advanced Surgical Products, Inc. · Apr 1988